Previous attempts at designing implantable venous valve prostheses have relied on a healthy sheep animal model in which the devices are implanted within the jugular vein. Investigators have also used healthy animal canine, porcine and bovine models with jugular and iliac vein implant sites. Questions remain, though, about whether these animal models provide a suitable hemodynamic environment for evaluating intraluminal medical devices intended for use in humans. For example, current animal models do not mimic the fluid dynamics of human veins. Specifically, the venous properties of humans are unique in that a reversal of flow opens and closes natural venous valves located within human veins. This reflux is attributable to the large hydrostatic column found in human veins. Quadrupeds lack such a hydrostatic gradient and, as a result, do not have degrees of reflux similar to humans.
Thus, a need remains for improved animal models useful in the evaluation of medical devices, including models useful in the evaluation of intraluminal medical devices, such as valve prostheses. A need also remains for improved methods of evaluating medical devices.